Substance Related Disorders

Behaviors and Mental Disorders

All Conditions

Alcoholism

Alcohol Drinking

Tobacco Use Disorder

Alcohol-Related Disorders

Substance-Related Disorders

Chemically-Induced Disorders

Mental Disorders

Psychotic Disorders

Anti-Infective Agents

Central Nervous System Depressants

All Drugs and Chemicals

Ethanol

To ensure that treatment effects are not due to the longer counseling intervention and additional alcohol intervention workbook in the Alcohol Intervention plus Standard Care condition, we will provide additional smoking cessation advice that will not be specific to alcohol use and an additional smoking cessation workbook for participants in the Practical Counseling plus Standard Care condition. Consistent with the Clinical Practice Guideline Update, we will include 5 minutes of practical counseling, which has been shown empirically to be effective in improving rates of smoking cessation.

Practical Counseling

The Alcohol Intervention counseling protocol will be adapted from Dr. Ockene's brief alcohol intervention protocol and Dr. Kahler's brief alcohol intervention for smokers: Feedback and discussion on the relationship between drinking and smoking, and on the potential effects of alcohol consumption on smoking cessation; an emphasis on personal Responsibility for choosing to change one's behavior; Advice to avoid or minimize drinking during the smoking cessation process; a Menu of options for carrying out a change strategy; use of Empathy by the clinician; and encouragement of Self-efficacy (i.e., confidence) for successful change.

Alcohol Intervention Counseling

Benjamin A. Toll, Ph.D.

The goal of this study is to train phone counselors working for the New York (NY) State Smokers' Quitline to advise callers who drink at hazardous levels to limit or abstain from alcohol use to determine whether this improves smoking cessation outcomes so that we can establish effect size estimates for a full scale multi-site trial.

This is a developmental study to: 1) create and beta test an alcohol counseling protocol with 25 Quitline callers and 2) train Quitline Specialists to provide an alcohol intervention using at least 100 pilot Quitline callers to ensure that Specialists in the alcohol intervention + standard care condition provide counseling that addresses hazardous drinking with a high level of alcohol intervention strategies and skill. After this phase of the study is complete, a developmental randomized clinical trial will be conducted with 1,948 NY Quitline callers who drink at hazardous levels to compare practical counseling + smoking cessation print materials added to standard care (PC + SC condition) to alcohol intervention counseling + alcohol-focused print materials added to standard care (AI + SC condition). Efficacy data from this trial will be used to determine effect size estimates for both quitdate and 7-month self-reported point prevalence abstinence rates. Reduction in alcohol consumption and reduced drinking as a mediator of smoking cessation outcome will be secondary outcomes. Other mediators and moderators of alcohol intervention effects will also be examined as an exploratory outcome. If the effect size estimates are sufficiently large and medically important to pursue a definitive trial, these data will be used to propose a full scale multi-site large study. If an alcohol intervention is shown to enhance treatment outcome in a large-scale study, alcohol interventions with quitline counselors could be translated for use by the entire NY state quitline and other quitlines across the country. This may increase the effectiveness of quitline interventions and thus has the potential to reach millions of smokers, thereby bolstering tobacco and cancer control efforts across the United States.

Alcohol Counseling for Telephone Quitline Callers

Advancing Tobacco and Cancer Control: Reducing Alcohol Use to Promote Smoking Cessation

To determine if advice to limit or abstain from alcohol use results in improved smoking cessation outcomes in 1,950 smokers who drink at hazardous levels and are calling a telephone Quitline.

To determine if advice to limit or abstain from alcohol use results in reduced alcohol consumption in 1,950 smokers who drink at hazardous levels and are calling a telephone Quitline.

To determine if reduction in alcohol use mediates smoking cessation success in 1,950 smokers who drink at hazardous levels and are calling a telephone Quitline.

To examine other mediators and moderators of smoking cessation effects to determine which factors and subgroups are more likely to respond to the alcohol intervention and discern mechanisms of treatment response

National Cancer Institute (NCI)

Yale University

Infections

Symptoms and General Pathology

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Immune System Diseases

Neoplasms

Rare Diseases

Communicable Diseases

Acquired Immunodeficiency Syndrome

HIV Infections

Sarcoma

Sarcoma, Kaposi

Disease Susceptibility

Neoplasms, Connective and Soft Tissue

Neoplasms by Histologic Type

Virus Diseases

Herpesviridae Infections

DNA Virus Infections

Neoplasms, Vascular Tissue

Soft Tissue Sarcoma

Kaposi Sarcoma

We propose to test, by DNA linkage analysis of family pedigree members, the following interrelated hypotheses: 1) that sexual orientation is genetically influenced; 2) that the development of Kaposi's sarcoma and other outcomes of HIV infection in male homosexuals is affected by host susceptibility genes, circulating sex hormone levels, or HLA haplotype; and 3) that alcoholism and other psychobehavioral conditions are associated with homosexuality on a genetic basis and/or influenced by candidate behavioral loci. The subjects for these studies will be self-identified male and female homosexual probands and their relatives from families in which there are at least two individuals with homosexual orientation. All subjects will be adults, and will be referred through NIH physicians, private practitioners, and gay and lesbian organizations. Subjects will undergo a sexual orientation and behaviors interview, a psychiatric interview, and phlebotomy for HIV testing, HLA determination, endocrine measurements, and preparation of DNA from cultured lymphocytes. The DNA samples will be analyzed for a series of genetic markers that span the human genome and for candidate loci chosen for function.

Genetic Factors and Interrelationships for Sexual Orientation, Susceptibility to HIV and Kaposi's Sarcoma, Alcoholism and Psychological Traits, and Histocompatibility Antigens

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Alcohol Counseling for Telephone Quitline Callers	NCT01120080	Smoking Nicotine Depend... Alcohol Depende...	Practical Couns... Alcohol Interve...	18 Years -	Yale University
Genetic Factors and Interrelationships for Sexual Orientation, Susceptibility to HIV and Kaposi's Sarcoma, Alcoholism and Psychological Traits, and Histocompatibility Antigens	NCT00001294	Alcoholism HIV Infection Homosexuality Kaposi's Sarcom...		-	National Institutes of Health Clinical Center (CC)
Alcohol Counseling for Telephone Quitline Callers	NCT01120080	Smoking Nicotine Depend... Alcohol Depende...	Practical Couns... Alcohol Interve...	18 Years -	Yale University

Spots Global Cancer Trial Database for alcohol dependence